Body fluid drainage container

ABSTRACT

A container for the collection of body fluids such as urine, has a semirigid tubular frame disposed within a flexible bag. The frame serves first as a supporting structure with its crossbar extending across the top of the bag and legs extending down the sides, thus preventing the bag from being bent across either vertical or horizontal axis. Secondly, the frame serves as a fluid conduit from a central inlet to the bag&#39;&#39;s main chamber. The lower part of each leg is cut away leaving an open channel to avoid any clogging of the fluid as it is discharged from the conduit into the main chamber.

United States Patent 3,187,750 6/1965 Tenczar, 128/214 X 3,259,920

[72] Inventor HarveyJ.EngeIsher Yonkers,N.Y.

7/1966 V0lIer.......... 1/1967 Whiteetal...................

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Bronx, N.Y.

[54] BODY FLUID DRAINAGE CONTAINER ABSTRACT: A container for the collection of such as urine, has a semir flexible .bag. The frame serves first as a su with its crossbar extending across the to extending down the sides, thus bent across either vertical or horizontal axis. frame serves as a fluid conduit from a central in let to the bags main chamber. The lower part of each leg is cutaway leaving an open channel to avoid any clogging of the fluid as it is discharged from the conduit into the main chamber.

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INVENTOR. HARVEY J. ENGELSHER BODY FLUID DRAINAGE CONTAINER BACKGROUND OF THE INVENTION AND DESCRIPTION OF THE PRIOR ART This invention relates to portable and disposable apparatus for use in draining and temporarily storing various body fluids. Drainage of these fluids by either natural or suction means is a very common and important medical procedure utilized for numerous conditions and treatments, of which urinary catheterization is one of the most significant. Samples of the urine accumulated by this procedure are generally subjected to standard urinalysis, culture tests, and specific gravity determination in the case of renal shutdown, whereby indications of numerous physical conditions and changes are monitored; and the remaining urine is then discarded.

The basic form of the apparatus for providing this drainage function is quite simple, comprising a catheter tube having one end inserted through the human urethra to the bladder and a discharge end which is directed into a container. One development in this field has been the use of flexible, plastic containers which are relatively easy to handle and are also readily disposable. In using such drainage apparatus there are three serious situations which may occur and endanger the patient. First, drainage may be halted by a blockage due to clogging of an aperture of a tube discharging into the containers interior chamber, or by a pinching or bending of the container and its interior tubing. In either case the consequences may be serious, particularly where it is assumed that drainage had stopped for other reasons. Since patients with catheters and urine collection containers still connected are often moved or wish to travel as is permitted, the containers are carried with frequent opportunities for these containers and their associated tubing to be bent with resultant blockages.

The second dangerous situation is infection caused by bacteria entering the draining system travelling upward to the bladder, ureters, and kidneys, and causing problems such as urinary sepsis, cystitis, and pyelonephritis. The bacteria may originate externally of the system and enter through the containers discharge valve, its breather valve or through the connection of the catheter and the containers inlet; also the bacteria may have been discharged by the patient into the container, with the bacteria subsequently returning upward through the container's inlet and then through the catheter. For these situations, attempted solutions include the use of antibacterial materials for the tubing, bacterial filters on the containers breather aperture, and a known airgap passage at the contiiners inlet, this last mentioned technique to reduce the possibility of a continuous moist return path by which the bacteria would travel upward from the liquid chamber to the catheter discharge. The third dangerous situation is backflow of urine from the container into the patients bladder which may occur if a careless or misinformed attendant or patient drops or causes inversion of a filled and still-connected container. Also bending of a filled container would produce a back pressure likely to result in backflow of the fluid.

SUMMARY OF THE INVENTION The new invention provides a body fluid drainage container which has features that substantially reduce the dangers of clogging and backflow, while the container is still made basically of flexible plastic sheet that is economical in manufacture and convenient to package This device which is connectable to the outlet end of a drainage tube such as a catheter is a basically closed container having walls formed of thin flexible, water-impermeable plastic sheet material defining a chamber between the, and a semirigid frame disposed inside the container. When the apparatus is in its upright position, the frame comprises a laterally extending tubular crossbar to which is attached at least one or preferably two tubular legs spaced apart and extending generally downward. Through the interior of the crossbar is a conduit which continues through the legs and discharges into the chamber, these frame members being substantially rigid to prevent bending of the containeralong with or vertical or horizontal axis.

The frames conduit is further provided with an inlet means having an upper tubular part with one end connectable to the outlet end of a drainage tube and a remote drip end, and a drip chamber which defines an enclosure about an air space. The drip chamber has its outlet connected to the upper tubular part, and a drip chamber connected to the conduit of the crossbar, with said drip end extending down to the drip chamber. The air space then separates the drip end or any extension of the drainage tube from the conduit, the air gap being a barrier to reverse travel of bacteria from the conduit back up into the drainage tube. In an upper section of the device is an inlet aperture through which the upper tubular part of the inlet means is extended and sealed; and in a lower section of one of the container walls is an outlet aperture and associated valve means for controlling discharge of accummulated fluid.

In a preferred embodiment each leg of the frame has an elongated slot in its sidewall to serve as a discharge aperture having a greater opening than the conduit diameter; this greatly reduces the possibility of clogging and blockage of the fluid flow. The new container is highly economical to manufacture, as the structure is very simple and the plastic parts can be heat-sealed together. While the frame provides sufficient rigidity to prevent the container from being bent (as protection against both blockage and backflowing of the fluid) the remainder of the container is made of flexible plastic sheet material, such that the device, when packaged and uninflated with the fluid is substantially flat occupying a minimum of space.

DESCRIPTION OF THE DRAWINGS The accompanying drawings show by way of example and without limitation to same, features of a preferred embodiment of the present invention.

FIG. 1 is a front elevation of a complete body fluid container.

FIG. 2 is a front elevation of the tubular frame.

FIG. 3 is a side elevation of the frame of FIG. 2.

FIG. 4 is a sectional view of the frame leg taken along lines 4-4 in FIG. 3.

FIG. 5 is a sectional view of the frame crossbar taken along lines 5-5 of FIG. 3.

FIG. 6 is a sectional view of the container taken along lines 66 in FIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENT The accompanying drawings show in an upright position, a preferred embodiment of a fully assembled body fluid drainage container of the present invention. In FIG. 1, this assembly 10 comprises a flexible container 11, a semirigid frame 12 disposed within the container, and a cord 13 for suspending the assembly. The frame, shown separately in FIGS. 2 and 3, is fonned of a tubular crossbar l4, tubular legs 15 extending downward from the ends of the crossbar, and an inlet subassembly 16. Within the crossbar is a conduit 17 which is continuous with conduit 18 through legs 15, this being shown in the sectional FIGS. 4 and 5 along with FIG. 2. In each leg a substantial portion of the tubular wall has been cut away from its end 19 upward to edge 20; this defines a long slot 21 as a discharge aperture which has a greater opening than the diameter of the conduits so that clogging is prevented.

The above frame is manufactured conveniently and economically by molding two shells, each defining one-half of the drip chamber, crossbar, and legs in channel-shaped cross section as shown in FIGS. 4 and5. The shells are then joined along their mutual edges 22 and heat-sealed into an integral body, the junction line of these edges also appearing in the side view of the frame in FIG. 3. When made of rigid polyvinylchloride, this body is sufficiently stiff to resist bending across the vertical horizontal, or other principal axes.

The inlet subassembly at the top of the frame includes an upper tubular part 23 including tube 24 for receiving the discharge end of a catheter, a drip chamber 25, and a lower part 26 having an outlet connected to the conduit 17 of the crossbar 14. In the neck of upper part 23 is secured a short tube 27 that extends downward with its lower end 28 in the midst of the bulbous drip chamber and spaced from all the walls thereof. Fluid discharged via the end 28 drips through an air space 29 (see FIG. 2) to conduit 17; the fluid is thus inhibited from flowing down wall 30 and from creating a continuous moist path between tube 27 and conduit 17 by which bacteria might travel upward to the catheter and to the patient. The lower end of tube 24 is secured within the upper end of tube 27, and the remote end (not shown) has means for receiving the discharge end of a catheter.

The flexible container 11 in FIG. 1 is formed of thin plastic sheet material such as polyvinylchloride about 7 mils thick, this material being water-impermeable, flexible, and heat scalable. After the completed frameis disposed inside the container between its front and rear walls 11a and 111:, the top, bottom, and side edges 31 are heat-sealed together. Also strips 32 and 33 immediately above and below crossbar 14 are heatsealed, strip 32 extending upward to and about upper part 23 of the inlet means.

Located in a generally upper portion of the containers front or rear walls lla, 11b, there is a breather valve 34 to permit a flow of air into or out of the container, while barring any passage of liquid or bacteria. This is achieved by securing across an aperture a microporous filter. A preferred filter material is one having nonwetting characteristics such that its outer surface will not become moist even if this inner surface is contacted by fluid within the container. On another part of one of the container walls is an external pocket 35 which is open only at the top 36. This pocket is convenient for receiv ing and temporarily holding the discharge end of a catheter either before its connection to the contanier's inlet tube or after its disconnection. Without such a pocket, it has been found that nurses and other attendants often allow the catheter tube end to dangle and contact unsterile objects Also shown on FIG. 1 is a discharge outlet and valve 37 located hear the bottom of the container. The valve shown is opened and closed by moving its outer sleeve axially and there is a secondary closure 38 that is removable secured over the sleeves outlet end. Obviously many other forms of valves would be quite satisfactory.

Optional structural features of this container shown in FIGS. 1 and 6 are stiffening members 39 secured and sealed between front and rear sheets 11a and 11b, and betweenheat seal 32 and the heat seal 31 along the top edge. These members 38 are made of semirigid cardboard, plastic or other material which becomes sealed and kept dry and separate from the fluid chamber. In both the sheets and the stiffener are apertures 40 through which a suspension cord 41 is threaded.

This cord, extended laterally about cars 31 at the upper corners, may have its remote portions looped over a patients' bed frame or other from which the container is then suspended.

In operation, body fluid such as urine flowing through a catheter, drips from inlet tube 27 into conduits 17 of the crossbar down conduits 18 of the legs and into the main chamber of the container. Graduated marks 42 on front wall 11a indicate the quantity of fluid accumulated, and discharge valve 37 permits emptying, unless the container is merely discarded with the fluid inside. unless frame 12 is prevents bending of the flexible container across any of this major axes. should a filled container be fully inverted, the accummulated liquid would flow through conduits 19 and 17 in the legs and crossbar, and then through tube 24, only until the fluid level dropped to edge 20. While this arrangement does not prevent all potential backflow, it is a useful safety feature.

In another of the above invention, there are structural features permitting the container to be self-standing. Generally triangular end panels of flexible plastic sheet may be secured between the front and rear walls, and a rectangular panel secured as a base. Secured to the outside surface of these front and rear walls are stiffening strips which support these walls as the fluid level rises. Since the bottom end of these stiffeners are spaced from the bottom ends of the tubular legs inside the container, these various ends provide separated support points for excellent stability.

What is claimed:

1. A body fluid drainage device for connection to the outlet end of a drainage tube such as a catheter, the device in its upright position, comprising:

a. a closed container formed of thin, flexible, water-impermeable plastic sheet material defining walls and a main chamber between the sheets, and upper and lower sections.

b. a semirigid frame formed of (i) a laterally extending tubular crossbar having a conduit therethrough, (ii) at least tow tubular legs spaced apart and extending generally downward from the crossbar, each leg having an internal passage connected to the conduit of the bar, and (iii) an inlet means having an upper tubular part with one end connectable to said outlet end of a drainage tube and a remote drip end, and a drip chamber defining an enclosure about an air space, this chamber having its inlet connected to said upper tubular part and its outlet connected to said conduit, with the drop end extending down into the drop chamber, and the air space thus separating said drip end and the conduit, the frame being secured inside the container with said inlet means extending out of the upper section of the container, the crossbar and legs preventing bending of the container, the crossbar and legs preventing bending of the container across these members, and

c. valve means connected to the outlet aperture of the container for controlling discharge of accumulated fluid at the lower section.

2. A device as defined in claim 1 wherein the franes crossbar, legs and inlet means comprise a unitary subassembly.

3. A device as defined claim 2 wherein said subassembly comprises tow mating shells, each part/defining one-half of the tubular frame cut by an axial plane.

4. A device as defined in claim 1 where in the lower part .of each leg has at least one aperture in the sidewall thereof.

5. A device in defined in claim 4 wherein the of part'each leg defines in a cross section a U-shaped channel, the aperture in the side of the leg thus being a slot.

6. A device as defined in claim 2 wherein the container is formed of two sheets heat-sealed together along their top, bottom, and side edges, with the upper part of the inlet mean extending between adjacent top edges of the two sheets and sealed therebetween.

7. A device as defined in claim 6 wherein the frames crossbar is spaced from the top edge of the container, with a margin of sheet material between said edge and the bar, the device further comprising means for stiffening said margin.

8. A device as defined in claim 7 wherein said means for stiffening comprises semirigid board material disposed between said marginal parts of said sheets and heat-sealed therebetween.

9. A device as defined in claim 1 including a breather aperture in an upper section of one of the sheets interconnecting the main chamber and the atmosphere, the device further comprising a filter covering the breather aperture, the filter formed of microporous material permitting passage of air and other gas while substantially barring any passage of liquid and bacteria.

10. A device as defined in claim 9 wherein said container sheets are flexible polyvinylchloride, the frame is rigid polyvinylchloride, and the filter is Teflon-coated fiber glass having 4-micron pores.

11. A device as defined in claim 1, wherein the container's sheets form (i) generally rectangular front and rear walls and a bottom, and (ii) generally triangular shaped end walls, with one point and an opposite side or each triangle at the containers top and bottom respectively, and wherein the legs of spaced form the bottom ends of the frame legs, where by the container when at least partially filled with fluid and disposed on a generally horizontal surface is stabilized to remain upright. 

1. A body fluid drainage device for connection to the outlet end of a drainage tube such as a catheter, the device in its upright position, comprising: a. a closed container formed of thin, flexible, waterimpermeable plastic sheet material defining walls and a main chamber between the sheets, and upper and lower sections. b. a semirigid frame formed of (i) a laterally extending tubular crossbar having a conduit therethrough, (ii) at least two tubular legs spaced apart and extending generally downward from the crossbar, each leg having an internal passage connected to the conduit of the bar, and (iii) an inlet means having an upper tubular part with one end connectable to said outlet end of a drainage tube and a remote drip end, and a drip chamber defining an enclosure about an air space, this chamber having its inlet connected to said upper tubular part and its outlet connected to said conduit, with the drop end extending down into the drip chamber, and the air space thus separating said drip end and the conduit, the frame being secured inside the container with said inlet means extending out of the upper section of the container, the crossbar and legs preventing bending of the container, the crossbar and legs preventing bending of the container across these members, and c. valve means connected to the outlet aperture of the container for controlling discharge of accumulated fluid at the lower section.
 2. A device as defined in claim 1 wherein the frane''s crossbar, legs and inlet means comprise a unitary subassembly.
 3. A device as defined claim 2 wherein said subassembly comprises two mating shells, each part/defining one-half of the tubular frame cut by an axial plane.
 4. A device as defined in claim 1 wherein the lower part of each leg has at least one aperture in the sidewall thereof.
 5. A device in defined in claim 4 wherein the lower part of each leg defines in a cross section a U-shaped channel, the aperture in the side of the leg thus being a slot.
 6. A device as defined in claim 2 wherein the container is formed of two sheets heat-sealed together along their top, bottom, and side edges, with the upper part of the inleT mean extending between adjacent top edges of the two sheets and sealed therebetween.
 7. A device as defined in claim 6 wherein the frame''s crossbar is spaced from the top edge of the container, with a margin of sheet material between said edge and the bar, the device further comprising means for stiffening said margin.
 8. A device as defined in claim 7 wherein said means for stiffening comprises semirigid board material disposed between said marginal parts of said sheets and heat-sealed therebetween.
 9. A device as defined in claim 1 including a breather aperture in an upper section of one of the sheets interconnecting the main chamber and the atmosphere, the device further comprising a filter covering the breather aperture, the filter formed of microporous material permitting passage of air and other gas while substantially barring any passage of liquid and bacteria.
 10. A device as defined in claim 9 wherein said container sheets are flexible polyvinylchloride, the frame is rigid polyvinylchloride, and the filter is Teflon-coated fiber glass having 4-micron pores.
 11. A device as defined in claim 1, wherein the container''s sheets form (i) generally rectangular front and rear walls and a bottom, and (ii) generally triangular shaped end walls, with one point and an opposite side or each triangle at the container''s top and bottom respectively, and wherein the legs of the frame extend downward to the container''s bottom, but are laterally spaced from the corner intersections of the side and bottom parts.
 12. A device as defined in claim 11 further comprising semirigid strips secured in generally vertical orientation on the front and rear walls, the strips having lower ends laterally spaced form the bottom ends of the frame legs, where by the container when at least partially filled with fluid and disposed on a generally horizontal surface is stabilized to remain upright. 